Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.Evaluation found there is scatter in the images and no clear outline of the mucosa information.There is nothing wrong with the fit on the plaster model or with the design in the planning file.
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It was reported that a surgiguide was used to create the osteotomy for three dental implants (tooth position 5, 6 and 7).After the first drilling step the surgical guide was removed to complete the additional drilling steps free handed according to the pilot guide drilling protocol.After placing the implants free handed, the customer discovered that the three implants were positioned too buccal.A second surgery is needed to correct the positioning of the implants.
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